Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

Background

Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.

Methods/Design

Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:

Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.

Ethics - beneficence, non-maleficence, autonomy, justice.

Economics - scarcity of resources, choices, opportunity costs.

For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.

Discussion

The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

Background

A US Food and Drug Administration (FDA) public health announcement, released to physicians in October 2008, highlighted concerns associated with the use of licensed mesh devices in the minimally invasive surgical repair of pelvic organ prolapse and stress urinary incontinence. The announcement reported serious complications resulting from the use of licensed devices from nine manufacturers, and pointed out that some of the complications led to significant decrease in patient quality of life with ongoing symptoms. The FDA memorandum stressed the need for surgeons to seek specialized training for each type of technique, to be vigilant about adverse events and complications, and highlighted the importance of informing patients about the potential for adverse events with possible long-term unpleasant effects on quality of life [1]. The information in the FDA announcement was reiterated in 2010 by the Health Canada Marketed Health Products Directorate [2]. These unusual announcements underline the dangers associated with the adoption of new licensed medical devices, and provide a reminder that the responsibility for patient outcome lies not only with regulators and device manufacturers, but also with policy makers and surgeons, and that patient should be active in the decision to have surgery performed.
The decisions surrounding the choice of medical device to approve (by device regulators), fund (by health care funding bodies) or adopt into clinical practice (by hospital authorities and clinicians) are affected by many different motivators and barriers, such as perceived effectiveness, safety (as highlighted by the FDA and Health Canada [1,2]), and also ethical and economic considerations. The research described in this protocol will examine specifically how ethics and economics influence stakeholders' decisions about adopting new devices, particularly when full information on effectiveness and safety may not be available.
In Canada, the licensing and use of new medical devices occurs within a health care system in which the adoption of new technologies is guided by ethics and economics as well as by clinical investigation: assuming that there is evidence that a new device is effective, the adoption of that device is subject to ethical and economic choices at all levels of the health care system. Ethics influences such decisions, seeking assurance that the device will benefit patients while not doing them disproportionate harm, that individuals are fully informed before they make decisions about adopting a new device, and that risks and benefits of a new treatment (or from withdrawing access to an older one) are fairly and reasonably distributed [3]. Economic theory offers further insights into the decision-making process, suggesting that in situations of limited resources, choices are necessary about which technologies should be adopted and which services should be sacrificed in order to free up resources [3-6]. Thus both ethics and economics are concerned with making good choices in adopting new health technologies, and may even be considered inseparable [3-6]. They are as fundamental to decisions about licensing and adopting new clinical devices, as considerations of clinical effectiveness and safety.

Licensing medical devices in Canada

The introduction of new medical devices in Canada is regulated by the Medical Devices Regulations of the Food and Drugs Act [7]. The process is governed by the Medical Device Regulatory Framework and undertaken by the Medical Device Bureau (MDB, one of the bureaux of the Health Canada Therapeutic Products Division). The mandate of MDB is specifically to evaluate and monitor the safety, efficacy and quality of diagnostic and therapeutic medical devices [8]. Manufacturers of medical devices require licenses to sell their products in Canada [9]: each new surgical device is classified according to risk, based on factors such as degree of invasiveness, duration of contact with patient, energy transmission hazard and consequences of device malfunction or failure. Risk class (Table 1) is allocated by comparing new devices to similar or competitive devices